Fresh off the clock, ex-FDA commish Robert Califf recently vented a few concerns he has with speeding up drug approvals. #1: Faster approval does nothing to address popular concern for the cost of drugs. Pharma will still say they must recoup hefty development costs and people will still not trust that explanation. #2: Are speed and safety at odds? As Califf puts it, “Declaring a drug safe after very little information is treacherous.” All drugs have risk and this risk is only uncovered through evidence. Check out 22 case studies where the bottom fell out between Phase II and III. And #3: Drugs can’t be approved faster if the FDA needs more FDA-ites – employees. We’re not sure what they call themselves.
A promising vaccine under development by Sanaria has some malaria strains running scared. The PfSPZ vaccine was shown to not only protect 64% of subjects from contracting the strain of malaria the treatment was developed from, the vaccine also protected 5 of the 6 subjects treated and exposed to a different strain. Sorry subject #6! Oh, and it does all this while affording eight months of protection at >90% efficacy, which no malaria vaccine to date has been able to do. It’s currently in Phase I, though it has been given fast track designation, so if it can survive the arduous clinical trials process it could be a very important tool in the fight to eradicate malaria.
Clinical trials are complex. They are costly. They take too long. They favor white people. Wait. What? According to an article in the New York Times, many cancer clinical trials are heavily weighted towards the white population. Why? They cite several reasons: most top cancer centers are not in rural locations; trials sponsored by industry do not have to have a specific mix of races; many minorities have chronic diseases that may exclude them from cancer trials. But the fact remains that cancer trials are weighted toward Caucasians. Maybe they’re easier to enroll, but should that matter? Maybe. Check out the FastPoll™ below and tell us what you think.
We’ve all had cuts and scrapes and most of them have healed pretty quickly. Well, the chronic wounds (i.e. diabetic ulcers) that affect 6 million US patients per year require a little more attention than antiseptic and a band aid. So much in fact that the US health care system spends an estimated $20B annually on treating these wounds. Cue the brilliant minds at Drexel University who have created a small, battery-powered, wearable device that uses low-frequency ultrasound to heal wounds. This caught the attention of the NIH who has awarded Drexel $3M to test the therapy over the next five years. Batteries make terrible band aids, but 6M patients a year means they’ll be in a lot of medicine cabinets.